LAIS
(2026)Objective
To test loberamisal, a dual-acting neuroprotective agent, for improving recovery in patients with moderate to severe acute ischemic stroke
Study Summary
• Safe profile with no increased risk of serious adverse events or death
• First successful Phase III neuroprotective agent trial in stroke
Intervention
Daily intravenous infusion of 40 mg loberamisal for 10 days versus matched placebo, started within 48 hours of stroke onset
Inclusion Criteria
Adults 18-80 years with confirmed acute ischemic stroke, NIHSS 7-20 (moderate to severe), treatment initiated within 48 hours of symptom onset
Study Design
Arms: Loberamisal 40 mg IV daily vs Placebo
Patients per Arm: 998 total patients (specific arm allocation not reported)
Outcome
• Safety: No increased risk of serious adverse events or death
• Treatment well-tolerated over 10-day course
Bottom Line
Loberamisal significantly improved excellent functional recovery at 90 days (69% vs 56%) with a favorable safety profile, representing the first successful Phase III neuroprotective agent trial in acute ischemic stroke
Major Points
- First successful Phase III trial of a neuroprotective agent for acute ischemic stroke
- 998 patients with moderate to severe stroke (NIHSS 7-20) across 32 centers in China
- 13% absolute increase in excellent functional recovery (mRS 0-1) at 90 days
- Dual-target mechanism designed to preserve neurovascular unit function
- Treatment initiated within 48 hours and continued for 10 days
- Safe profile with no increased serious adverse events or mortality
- Only 17% received IV thrombolysis, limiting assessment of combined effects
Study Design
- Study Type
- Phase III randomized controlled trial
- Randomization
- Yes
- Blinding
- Double-blind, placebo-controlled with computer-generated randomization; neither investigators nor participants knew treatment assignment
- Sample Size
- 998
- Follow-up
- 90 days
- Centers
- 32
- Countries
- China
Primary Outcome
Definition: Excellent functional recovery defined as modified Rankin Scale score 0-1 (little to no disability) at 90 days
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 56% | 69% | - |
Limitations & Criticisms
- Conducted only in China, limiting generalizability to other populations and ethnic groups
- Only 17% received IV thrombolysis, limiting assessment of combined neuroprotection with reperfusion therapy
- Most patients had moderate stroke severity (NIHSS 7-20), may not apply to very severe strokes
- Patients who received mechanical thrombectomy were excluded, limiting real-world applicability
- No biomarkers (blood or imaging) assessed to understand mechanism of action
- Short follow-up duration (90 days only)
- Preliminary results from conference presentation, full publication pending peer review
- Specific numbers for each treatment arm not reported in press release
Citation
Late-Breaking Science Presentation, ISC 2026, New Orleans